510(k) K002591 ยท DTP Defoamer, Cardiopulmonary Bypass
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Sep 13, 2000 |
| Received | Aug 21, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002591
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.